Associate Director, Quality Control

Job Title: Associate Director Quality Control

Location: Exton, PA

Type: Contract to hire

Schedule: Monday – Friday Day Hours

Responsibilities:

Manage a staff of Quality Control analysts and Environmental Monitoring specialists ensuring that day-to-day scheduling of activities is appropriately resourced

Maintenance of the viable and non-viable Environmental Monitoring Program, including monthly trend analysis, yearly alert and action level evaluation, equipment upkeep, logbook review, and order status

Manage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systems

Ensure all method qualification and validation is current. Test procedures include bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays (additional analytical platforms maybe implemented as per business needs)

Keep apprised of compendial changes and ensure compliance with compendia for all test procedures

Manage external vendors providing lab services and materials

Maintain appropriate inventory of materials through effective order management, coordination with Finance, and adherence to departmental budget

Ensure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final Drug Product

Participate in the establishment of phase-appropriate specifications

Ensure data integrity is maintained for all applications, programs, and executed work

Generation of protocols, technical reports, and other documentation as needed

Author and manage QC change controls, test procedure revisions, SOP revisions, laboratory investigations, root cause analyses, and risk assessment as needed

Raise critical quality issues to upper management

Perform internal audits to ensure compliance with cGMP’s

Write and revise Quality Systems SOPs and other documentation as necessary to maintain compliance

Training and development of employees

Support audit of external parties and regulatory inspections

Ensure full compliance with applicable health and safety regulations (such as OSHA)

Willingness to engage with a high energy team in pursuit of organizational goals and strategies

Requirements:

Minimum Bachelor of Science degree in a relevant scientific discipline

Minimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management experience in Quality Control or Quality Assurance

Excellent knowledge of cGMP guidelines, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standards

Technical writing experience in a similar role in the biologics or pharmaceutical industry

Experience in aseptic processing and/or mammalian cell culture production

Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills

Ability to prioritize and successfully execute multiple tasks simultaneously

Ability to work with a high degree of accuracy and detail

Positive work attitude that supports teamwork and continuous improvement

#M3

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.